A Chemistry laboratory analyst experienced in analytical support for the manufacture, release, and stability testing of GMP drug substance produced at Allergan DSO.Contributes to the completion of specific programs and projects. Failure to obtain results, or erroneous decisions, would result in major program delays and considerable expenditure of resources.
*Good organizational skills and work ethics
*Operates effectively in a fast paced work environment
*Flexibility in a dynamic work environment
*Good interpersonal and strong written/verbal communication skills
*Well developed skills in prioritizing, organization and time management
*Experience in a cGMP pharmaceutical research and/or development environment
*Strong analytical and HPLC skills
*High level of understanding in chromatography data collection/processing software, Empower
*Ability to interpret and evaluate data and summarize results
Microsoft Office (Excel, Word, PowerPoint)
HPLC Chromatography Technical Analysis
Accelerated Release Profile Analysis
Wet Chemistry Analysis
Thin Layer Chromatography
Viscosity and Rheometer Analysis
Leachables, Baseline and Related Substance Analysis
CAD and RI Detector Analysis
Professional Laboratory Analyst September 1998 to June 2015Allergan Inc － Irvine, CA
Provides analytical support for stability testing of clinical, toxicology and finished pharmaceutical products for the completion of specific programs and projects.
Generates and evaluates accurate and precise data for samples used in stability, raw materials, clinical and toxicology studies and other requested testing according to Standard Operating Procedures (SOP) and validated analytical methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements.
Write standard protocols and technical reports to address technical issues and/or support product registration efforts.
Generates stability data tables and plots in support of specification development and regulatory submissions.
Identifies any atypical data and report to supervisor with probable causes and suggests resolution.
Completes deviation reports and perform investigations of out of specification and out of trend results thru QMS (Quality Management System).
Coordinates work request system to support special project studies and expedited processing for completeness.
Reviews analytical methods and provides feedback in support to development projects, validation and special studies.
Maintains a current knowledge and understanding of global regulatory stability requirements and expectations as well as cGMP practices.
Calibrates and troubleshoots instrumentation problems and propose solutions with minimum guidance from supervisor.
Assists and train peers on fundamental laboratory techniques.
B.S : ChemistryFar Easter University － Manila, PhilippinesChemistry